Title: Resuming Operations During a Pandemic

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19. Q. We are a manufacturer of prescription pharmaceuticals, and we experienced many disruptions to our operations because of the COVID-19 restrictions. This made it difficult to fully comply with current good manufacturing practices (CGMPs). Is there a regulatory agency expectation by when we need to be back in compliance?

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   Person Information
   Application Sequencing
 325412 - Pharmaceutical Preparation Manufacturing                
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Manufacturing

 

 

 

 

  • Pharmaceutical Technology

 

  • 11/2/2020

 

  • Article